A Phase 4 interventional study of Loceryl Nail Lacquer and Urea Ointment in Foot Dermatoses, sponsored by Galderma R&D. Completed at 1 site in Iceland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-17.
Sponsored by Galderma R&D · Phase 4, Interventional, and Treatment
The main objective of this study is to compare subject adherence and satisfaction for two modes of treatment toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and a Fungal Nail Treatment Set containing Urea 40% ointment (Urea) and Bifonazole cream 1% (Bifonazole).
A total of 20 subjects are to be included in 1 site in Iceland
Methodology:
Subjects will receive following treatments on the right or left toenails:
Fungal Nail Treatment Set to be used on all affected toenails (including great toenail) of the opposite foot in two phases:
147 studies on the registry are indexed under Onychomycosis; 13 are open to participants now.
This study's enrollment of 22 is below the median of 56 across 134 interventional studies indexed under Onychomycosis.
Browse Onychomycosis studies →Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Amorolfine hydrochloride NL 5% to be applied once weekly for 7 weeks on all affected toenails of one foot
Drug: Loceryl Nail Lacquer
On the opposite foot: 1. Urea 40% ointment to be applied once a day under occlusion for 2-3 weeks depending on the achievement of optimal diseased toenail plates removal) 2. Bifonazole 1% cream to be applied for 4 weeks on affected toenails (after the maximum 3-week treatment period with Urea ointment)
Drug: Urea Ointment · Drug: Bifonazole Cream
Topical over entire toenail plates of affected toenails once weekly in the evening (at bed time) after having filled down affected toenails to gently remove as much as affected nails and having cleaned toenails surfaces with the provided cleansing swab
Also known as: Loceryl NL
Topical over the infected part of the toenails only once daily under occlusion in the evening (at bed time) after having soaked toenails in warm water and having removed the soften infected toenail plates and dried the toenails
Also known as: Urea
Topical, to be rubbed sparingly over the affected toenail skin (nail bed) once daily in the evening (at bed time) after having cleaned and dried thoroughly toenails
Also known as: Bifonazole
% adherent subjects with applications
Percent of subjects having applied both study treatments as instructed (once a week for Loceryl NL, once a day for urea and once a day for Bifonazole)
Time frame: Week 7
% adherent subjects with nail preparation
Percent of subjects having prepared affected toenails as instructed for each product before applications: * For Loceryl: File down the affected toenails as required and clean toenails surface with the cleansing swab * For Urea: Soak toenails in warm water and remove soften infected toenails plates * For Bifonazole: Clean and dry thoroughly affected toenails
Time frame: Week 7
% Subjects satisfied to very satisfied with each study treatment at week 7
Percent of subjects satisfied to very satisfied with each study treatment at week 7
Time frame: Week 7
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Galderma R&D